Mylan Laboratories Ltd. v. Janssen Pharmaceutica, N.V.

989 F.3d 1375
CourtCourt of Appeals for the Federal Circuit
DecidedMarch 12, 2021
Docket21-1071
StatusPublished
Cited by37 cases

This text of 989 F.3d 1375 (Mylan Laboratories Ltd. v. Janssen Pharmaceutica, N.V.) is published on Counsel Stack Legal Research, covering Court of Appeals for the Federal Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Mylan Laboratories Ltd. v. Janssen Pharmaceutica, N.V., 989 F.3d 1375 (Fed. Cir. 2021).

Opinion

Case: 21-1071 Document: 32 Page: 1 Filed: 03/12/2021

United States Court of Appeals for the Federal Circuit ______________________

MYLAN LABORATORIES LTD., Appellant

v.

JANSSEN PHARMACEUTICA, N.V., Appellee

ANDREW HIRSHFELD, PERFORMING THE FUNCTIONS AND DUTIES OF THE UNDER SECRETARY OF COMMERCE FOR INTELLECTUAL PROPERTY AND DIRECTOR OF THE UNITED STATES PATENT AND TRADEMARK OFFICE, Intervenor ______________________

2021-1071 ______________________

Appeal from the United States Patent and Trademark Office, Patent Trial and Appeal Board in No. IPR2020- 00440. ______________________

ON MOTION ______________________

DEEPRO MUKERJEE, Katten Muchin Rosenman LLP, New York, NY, argued for appellant. Also represented by LANCE SODERSTROM; JOHNJERICA HODGE, ERIC THOMAS WERLINGER, Washington, DC; JITENDRA MALIK, Charlotte, Case: 21-1071 Document: 32 Page: 2 Filed: 03/12/2021

NC.

PRATIK A. SHAH, Akin Gump Strauss Hauer & Feld LLP, Washington, DC, argued for appellee. Also repre- sented by Z.W. JULIUS CHEN; RUBEN H. MUNOZ, Philadel- phia, PA; ANDREW D. COHEN, BARBARA MULLIN, Patterson Belknap Webb & Tyler LLP, New York, NY.

MELISSA N. PATTERSON, Appellate Staff, Civil Division, United States Department of Justice, Washington, DC, ar- gued for intervenor. Also represented by WEILI J. SHAW; MICHAEL S. FORMAN, MARY L. KELLY, THOMAS W. KRAUSE, FARHEENA YASMEEN RASHEED, MOLLY R. SILFEN, Office of the Solicitor, United States Patent and Trademark Office, Alexandria, VA. ______________________

Before NEWMAN, MOORE, and STOLL, Circuit Judges. MOORE, Circuit Judge. ORDER Mylan Laboratories Ltd. appeals a Patent Trial and Appeal Board (Board) decision that denied institution of in- ter partes review (IPR) for U.S. Patent No. 9,439,906. Mylan Labs. Ltd. v. Janssen Pharmaceutica, N.V., No. IPR2020-00440, 2020 WL 5580472 (P.T.A.B. Sept. 16, 2020) (Board Decision). It also seeks mandamus relief. 1 Janssen, the patent owner, moves to dismiss Mylan’s

1 Mylan cited the All Writs Act, 28 U.S.C. § 1651, in its Notice of Appeal and requested mandamus at argu- ment. See Notice of Appeal at 1. We hold that sufficient to seek mandamus relief in the circumstances of this case. GTNX, Inc. v. INTTRA, Inc., 789 F.3d 1309, 1312 (Fed. Cir. 2015) (interpreting notice of appeal that cited § 1651 as seeking mandamus). Case: 21-1071 Document: 32 Page: 3 Filed: 03/12/2021

MYLAN LABS. LTD. v. JANSSEN PHARMACEUTICA, N.V. 3

appeal for lack of jurisdiction. The United States Patent and Trademark Office (Patent Office) intervened and sup- ports Janssen’s motion. Because we lack jurisdiction over appeals from decisions denying institution, we grant Janssen’s motion to dismiss. Although we have jurisdic- tion over mandamus petitions challenging such decisions, Mylan has not shown it is entitled to such an extraordinary remedy. Thus, we dismiss Mylan’s appeal and deny its re- quest for mandamus. BACKGROUND In 2019, Janssen sued Mylan in district court for in- fringing certain claims in the ’906 patent. Less than six months later, Mylan petitioned for IPR of that patent. It raised four grounds for the unpatentability of certain claims, all based on 35 U.S.C. § 103. Opposing institution, Janssen claimed IPR would be an inefficient use of Board resources because of two co-pending district court actions: the suit against Mylan and another suit against Teva Phar- maceuticals USA, Inc. It argued the validity issues in those co-pending actions overlapped with Mylan’s petition and that both actions would likely reach final judgment be- fore any IPR final written decision. The Board agreed with Janssen and denied institution. Board Decision at *1–11. In exercising its discretion, the Board applied its six-factor standard for evaluating whether to deny institution in view of an earlier trial date in a co-pending district court proceeding. See Apple v. Fin- tiv, IPR2020-00019, 2020 WL 2126495 (P.T.A.B. Mar. 20, 2020) (precedential) (the Fintiv factors 2). It found

2 The factors are: “(1) whether the [district] court granted a stay or evidence exists that one may be granted if a proceeding is instituted; (2) proximity of the [district] court’s trial date to the Board’s projected statutory dead- line for a final written decision; (3) investment in the Case: 21-1071 Document: 32 Page: 4 Filed: 03/12/2021

substantial overlap between the issues raised in Mylan’s IPR petition and the co-pending district court actions. It also found both district court actions would likely reach fi- nal judgement before any final written decision. The Board, in part, relied on the Teva trial date, which was only a few weeks away. Thus, the Board concluded it would be an inefficient use of resources to institute IPR. Mylan appeals. It claims “(1) that the Board’s determi- nation to deny institution . . . based on the timing of a sep- arate district-court litigation to which Petitioner is not a party, undermines Petitioner’s constitutional and other due process rights; and (2) the Board’s continued adoption and application of non-statutory institution standards through ad hoc proceedings lie in contrast to congressional intent.” Notice of Appeal at 1. It also requests mandamus relief on the same grounds. DISCUSSION Janssen’s motion implicates two distinct jurisdictional questions: first, whether we have jurisdiction over Mylan’s direct appeal, and second, whether we have jurisdiction over Mylan’s request for mandamus. We address each question in turn. I The jurisdiction of federal courts is limited to those cases and controversies delineated in Article III of the Con- stitution. And the “[j]urisdiction of the lower federal courts

parallel proceeding by the [district] court and the parties; (4) overlap between issues raised in the petition and in the parallel proceeding; (5) whether the petitioner and the de- fendant in the parallel proceeding are the same party; and (6) other circumstances that impact the Board’s exercise of discretion, including the merits.” Apple v. Fintiv, IPR2020- 00019, 2020 WL 2126495, at *2 (P.T.A.B. Mar. 20, 2020). Case: 21-1071 Document: 32 Page: 5 Filed: 03/12/2021

MYLAN LABS. LTD. v. JANSSEN PHARMACEUTICA, N.V. 5

is further limited to those subjects encompassed within a statutory grant of jurisdiction.” Ins. Corp. of Ireland v. Compagnie des Bauxites de Guinee, 456 U.S. 694, 701 (1982). Because no statute grants us jurisdiction over ap- peals from decisions denying institution, we must dismiss Mylan’s direct appeal. Our general grant of jurisdiction, 28 U.S.C. § 1295(a)(4), and the appeal bar, 35 U.S.C. § 314(d), are most relevant here. Read together, those statutes preclude direct appeal from a decision denying institution: • § 1295(a)(4): [We] shall have exclusive jurisdic- tion . . . of an appeal from a decision of [Board] with respect to . . . inter partes review . . . . • § 314(d): No Appeal. The determination by the Director whether to institute an inter partes re- view under this section shall be final and non- appealable. (emphases added). At a first glance, the “appeal from a de- cision” language in § 1295(a)(4) seems broad, perhaps broad enough to reach an appeal from a decision denying institution. But § 314(d), the more specific statute, dispels any such notion.

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989 F.3d 1375, Counsel Stack Legal Research, https://law.counselstack.com/opinion/mylan-laboratories-ltd-v-janssen-pharmaceutica-nv-cafc-2021.